First of all, in this post I AM NOT implying that Histogen will be approved and become available soon in the US. There is a slim chance it might happen within 2 years or so, but most likely it will be on the far side of that.
However, when it does happen, this is what I think they will be FORCED by the FDA to do… and mark my words.
We already know that all the protocols they’ve been testing, all the reports, summaries, descriptions, studies, etc. about Histogen’s “Hair Stimulating Complex”, HSC, entail the following: THE SCALP INJECTIONS ARE LIMITED TO ABOUT 2-3 SESSIONS PER YEAR, NO MORE.
Never once, anywhere to my knowledge, have they ever tested or publicized a study or clinical trial where they administer these HSC injections more than about twice a year (i.e., once every 6 months).
If anyone can show me evidence that they’ve tested it for more frequent treatments, please speak now.
This means that they already KNOW that no regulatory agency will approve anything more frequent. This is a done deal.
Why? Because HSC contains growth factors that are known to be involved with serious potential side effects, like cancer, when too much of these growth factors are absorbed from exogenous sources into the body.
For example, VEGF, which is in HSC, is thought to promote the growth of cancerous tumors, when absorbed in too-high quantities. Therefore the FDA will be VERY CAREFUL about what they eventually approve, when reviewing Histogen’s application.
I realize these growth factors are already present in the body and are just lab-synthesized versions of what already is produced in the body.
The issue is not where they come from, the issue is QUANTITY. How much can safely be put into the body from an outside source, with the approval of the government? The FDA will deem there are reasonable limits to this.
I know that some people are wildly bandying about scenarios where they’ll be able to get HSC injections, say, once a month or every week.
I’d have to say that’s bunk… the wildest and most unrealistic type of pie-in-the-sky dreaming.
So, here’s what I can predict Histogen will be FORCED BY THE FDA to do in the USA:
HSC will be administered by physicians only. Only doctors will be authorized to prescribe it and administer it. It will be impossible for you to legally buy HSC and inject it into your own scalp, unless you somehow manage to get it on the black market.
ALL doctors who want to treat their patients with HSC will have to register to obtain it. Their registration information will go into a big database, and Histogen, along with the FDA, will monitor this database in real time.
Any patient who wants to get HSC treatment will be able to get it from only one physician or clinic at a time.
It will be unlawful for a patient to have more than, say, 2-3 injection sessions of HSC per year.
Any patient who tries to circumvent this rule by obtaining more frequent injections, say, by visiting multiple doctors in multiple cities, will be immediately caught when his name shows up multiple times in the database. He will be instantly prohibited from obtaining more HSC injections than the prescribed (for example) 2-3 treatments per year.
Furthermore the FDA will make their approval of HSC conditional on Histogen agreeing to all of the above.